Duns Number:002348191
Device Description: RUSCH GREENLITE SU MTL BLADE MAC 3.5
Catalog Number
004551035
Brand Name
RUSCH
Version/Model Number
IPN048388
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2019
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCW
Product Code Name
LARYNGOSCOPE, RIGID
Public Device Record Key
55d64c24-758a-4c3e-a14c-ffa638c9c3ea
Public Version Date
January 08, 2020
Public Version Number
3
DI Record Publish Date
September 15, 2018
Package DI Number
34026741626092
Quantity per Package
20
Contains DI Package
14026740626099
Package Discontinue Date
February 21, 2019
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |